{
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"NDCCode": "57664-167-58",
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"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-167-08",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-167-08)",
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},
{
"NDCCode": "57664-167-18",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-167-18)",
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"Status": "Deprecated",
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},
{
"NDCCode": "57664-167-52",
"PackageDescription": "100 TABLET in 1 BOTTLE (57664-167-52) ",
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"ProductNDC": "57664-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-167-59",
"PackageDescription": "90 TABLET in 1 BOTTLE (57664-167-59) ",
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"ProductNDC": "57664-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"SubstanceName": "METOPROLOL TARTRATE",
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"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150629",
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"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-167-99",
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"ProductNDC": "57664-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA074644",
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"SubstanceName": "METOPROLOL TARTRATE",
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"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "57664-162-58",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-162-58) ",
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"ProductNDC": "57664-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
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"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-166-58",
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"SubstanceName": "METOPROLOL TARTRATE",
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"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-397-58",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin."
},
{
"NDCCode": "57664-435-58",
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"ProductNDC": "57664-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
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"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
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"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20020129",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin."
},
{
"NDCCode": "57664-474-58",
"PackageDescription": "1000 TABLET in 1 BOTTLE (57664-474-58) ",
"NDC11Code": "57664-0474-58",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20020129",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin."
},
{
"NDCCode": "57664-477-58",
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"ProductNDC": "57664-477",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20150629",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "57664-506-58",
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"RouteName": "ORAL",
"StartMarketingDate": "20150629",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076670",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150629",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .",
"Description": "Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide."
},
{
"NDCCode": "16571-167-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-167-01) ",
"NDC11Code": "16571-0167-01",
"ProductNDC": "16571-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxazosin",
"NonProprietaryName": "Doxazosin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212727",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "DOXAZOSIN MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240520",
"SamplePackage": "N",
"IndicationAndUsage": "Doxazosin tablets are an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.",
"Description": "Doxazosin mesylate, USP is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 CH4O3S and the molecular weight is 547.58. It has the following structure. Doxazosin mesylate, USP is freely soluble in formic acid, very slightly soluble in water and Methanol. Doxazosin tablets are available as colored tablets for oral use and contains 1 mg (white), 2 mg (white), 4 mg (white) and 8 mg (white) of doxazosin as the free base. The inactive ingredients for all tablets are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, Colloidal Silicon dioxide and magnesium stearate."
},
{
"NDCCode": "27241-167-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (27241-167-01) ",
"NDC11Code": "27241-0167-01",
"ProductNDC": "27241-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191220",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "27241-167-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (27241-167-10) ",
"NDC11Code": "27241-0167-10",
"ProductNDC": "27241-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212624",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200220",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3."
},
{
"NDCCode": "60687-719-25",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (60687-719-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-719-95) ",
"NDC11Code": "60687-0719-25",
"ProductNDC": "60687-719",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231023",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212689",
"LabelerName": "American Health Packaging",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "200; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231023",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "HIV-1 Treatment (1.1) Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: : 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine, USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.30. It has the following structural formula:. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
},
{
"NDCCode": "67296-1830-7",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (67296-1830-7) ",
"NDC11Code": "67296-1830-07",
"ProductNDC": "67296-1830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210324",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212689",
"LabelerName": "Redpharm Drug, Inc.",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "200; 300",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210324",
"SamplePackage": "N",
"IndicationAndUsage": "HIV-1 Treatment ( 1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.30. It has the following structural formula:. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
},
{
"NDCCode": "70710-1364-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70710-1364-3) ",
"NDC11Code": "70710-1364-03",
"ProductNDC": "70710-1364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212689",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "HIV-1 Treatment (1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
},
{
"NDCCode": "70710-1364-4",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (70710-1364-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1364-2) ",
"NDC11Code": "70710-1364-04",
"ProductNDC": "70710-1364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212689",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210701",
"SamplePackage": "N",
"IndicationAndUsage": "HIV-1 Treatment (1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
},
{
"NDCCode": "70710-1364-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (70710-1364-9) ",
"NDC11Code": "70710-1364-09",
"ProductNDC": "70710-1364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"NonProprietaryName": "Emtricitabine And Tenofovir Disoproxil Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212689",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE",
"StrengthNumber": "100; 150",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Active",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210701",
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"IndicationAndUsage": "HIV-1 Treatment (1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.",
"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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"Description": "Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients."
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<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57664-162-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-162-58) </PackageDescription>
<NDC11Code>57664-0162-58</NDC11Code>
<ProductNDC>57664-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>57664-166-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-166-58) </PackageDescription>
<NDC11Code>57664-0166-58</NDC11Code>
<ProductNDC>57664-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>57664-397-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-397-58) </PackageDescription>
<NDC11Code>57664-0397-58</NDC11Code>
<ProductNDC>57664-397</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075967</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>57664-435-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-435-58) </PackageDescription>
<NDC11Code>57664-0435-58</NDC11Code>
<ProductNDC>57664-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075967</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>850</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>57664-474-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-474-58) </PackageDescription>
<NDC11Code>57664-0474-58</NDC11Code>
<ProductNDC>57664-474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075967</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and 4 11 5 is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% a aqueous solution of metformin hydrochloride, USP is 6.68. Metformin hydrochloride tablets USP contain 500 mg, 850 mg and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition the coating for 500 mg, 850 mg and 1000 mg contains: lactose monohydrate, hypromellose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>57664-477-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-477-58) </PackageDescription>
<NDC11Code>57664-0477-58</NDC11Code>
<ProductNDC>57664-477</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>57664-506-58</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (57664-506-58) </PackageDescription>
<NDC11Code>57664-0506-58</NDC11Code>
<ProductNDC>57664-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150629</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076670</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris. ( 1.2) , 3 Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients ( 1.3) .</IndicationAndUsage>
<Description>Metoprolol tartrate tablets, USP contain metoprolol tartrate, a selective beta 1-adrenoreceptor blocking agent. Metoprolol tartrate is (±)-1-(Isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol L-(+)-tartrate (2:1) salt, and its structural formula is. Metoprolol tartrate USP is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water; freely soluble in methylene chloride, in chloroform, and in alcohol; slightly soluble in acetone; and insoluble in ether. Metoprolol tartrate tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration containing 25 mg, 50 mg and 100 mg metoprolol tartrate, respectively. Inactive Ingredients: Tablets contain colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, sodium starch glycolate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>16571-167-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16571-167-01) </PackageDescription>
<NDC11Code>16571-0167-01</NDC11Code>
<ProductNDC>16571-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxazosin</ProprietaryName>
<NonProprietaryName>Doxazosin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212727</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxazosin tablets are an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
<Description>Doxazosin mesylate, USP is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C23H25N5O5 CH4O3S and the molecular weight is 547.58. It has the following structure. Doxazosin mesylate, USP is freely soluble in formic acid, very slightly soluble in water and Methanol. Doxazosin tablets are available as colored tablets for oral use and contains 1 mg (white), 2 mg (white), 4 mg (white) and 8 mg (white) of doxazosin as the free base. The inactive ingredients for all tablets are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, Colloidal Silicon dioxide and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>27241-167-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (27241-167-01) </PackageDescription>
<NDC11Code>27241-0167-01</NDC11Code>
<ProductNDC>27241-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>27241-167-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (27241-167-10) </PackageDescription>
<NDC11Code>27241-0167-10</NDC11Code>
<ProductNDC>27241-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212624</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>Doxepin is a tricyclic antidepressant. The molecular formula of doxepin hydrochloride, USP is C19H21NOHCl with a molecular weight of 315.84. It is a white or almost white crystalline powder freely soluble in water, in alcohol and methylene chloride. Doxepin is a dibenzoxepin derivative. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-, hydrochloride. The structural formula of doxepin is shown below. Doxepin hydrochloride, USP. Doxepin hydrochloride capsules, USP is for oral administration. Active ingredients for the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, 100 mg, and 150 mg of doxepin (equivalent to 11.31 mg, 28.26 mg, 56.53 mg, 84.79 mg, 113.05 mg, and 169.58 mg of doxepin hydrochloride, respectively). Capsule inactive ingredients: microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and magnesium stearate. The hard gelatin capsule shell contains titanium dioxide, gelatin, sodium lauryl sulfate, FD & C Yellow 6, D & C Yellow 10 and FD & C Green 3. The imprinting ink contains shellac, propylene glycol, black iron oxide and potassium hydroxide. Doxepin hydrochloride capsules meet USP Dissolution Test 3.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine, USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.30. It has the following structural formula:. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C 8H 10FN 3O 3S and a molecular weight of 247.30. It has the following structural formula:. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[( R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19H 30N 5O 10P C 4H 4O 4 and a molecular weight of 635.52. It has the following structural formula:. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<IndicationAndUsage>HIV-1 Treatment (1.1). Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: 1 in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.</IndicationAndUsage>
<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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<Description>Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine,USP (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Both FTC and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine, USP. The chemical name of FTC is 4-Amino-5-fluoro-1-[(2R,5S)-2-(hydroxymethyl)-1,3 oxathiolan-5-yl]-2(1H)-pyrimidinone. FTC is the (-) enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5-position. It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.30. It has the following structural formula. FTC is a white to almost white crystalline powder with a solubility of approximately 100.03 mg/mL in water at 25°C. It is freely soluble in methanol and practically insoluble in dichloromethane. The partition coefficient (log p) for emtricitabine is -1.07 and the pKa is 2.27. Tenofovir Disoproxil Fumarate. TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy] phosphinyl] methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P C4H4O4 and a molecular weight of 635.52. It has the following structural formula. Tenofovir disoproxil fumarate is a white to off-white powder with a solubility of 7.58 mg/mL in water at 25°C. It is freely soluble in dimethylformamide and soluble in methanol. The partition coefficient (log p) for tenofovir disoproxil is 0.75 and the pKa is 3.95. All dosages are expressed in terms of TDF except where otherwise noted. Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration and are available in the following strengths: 1 Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients, 2 Film-coated tablet containing 167 mg of FTC and 250 mg of TDF (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients, 3 Film-coated tablet containing 133 mg of FTC and 200 mg of TDF (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients, 4 Film-coated tablet containing 100 mg of FTC and 150 mg of TDF (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients.</Description>
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